U.S. patent number 9,861,432 [Application Number 14/204,087] was granted by the patent office on 2018-01-09 for rotation mechanism for bipolar and monopolar devices.
This patent grant is currently assigned to Cook Medical Technologies, LLC. The grantee listed for this patent is Cook Medical Technologies LLC. Invention is credited to Shaun D. Gittard, Jillian Haac, Kenneth C. Kennedy, II.
United States Patent |
9,861,432 |
Gittard , et al. |
January 9, 2018 |
Rotation mechanism for bipolar and monopolar devices
Abstract
An electrosurgical device and a method of orienting the
electrosurgical device are provided. The device includes a rotation
mechanism including a first and a second connector where the first
connector is rotatable relative to the second connector. The device
also includes a handle operably connected to the first connector;
and a catheter operably connected to the second connector where the
handle is rotatable relative to the catheter. The device further
includes a first wire having a distal portion anchored to a distal
portion of the catheter so that the distal portion of the wire is
orientable by rotation of the handle relative to the catheter. At
least one of the rotation mechanism or a proximal portion of the
wire forms a conductive connection that operably connects a power
source to the distal portion of the first wire to energize the
distal portion of the first wire in the electrosurgical device.
Inventors: |
Gittard; Shaun D.
(Winston-Salem, NC), Haac; Jillian (Winston-Salem, NC),
Kennedy, II; Kenneth C. (Clemmons, NC) |
Applicant: |
Name |
City |
State |
Country |
Type |
Cook Medical Technologies LLC |
Bloomington |
IN |
US |
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Assignee: |
Cook Medical Technologies, LLC
(Bloomington, IN)
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Family
ID: |
50240027 |
Appl.
No.: |
14/204,087 |
Filed: |
March 11, 2014 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20140276808 A1 |
Sep 18, 2014 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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61779986 |
Mar 13, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
18/1492 (20130101); A61B 2018/00202 (20130101); A61B
2018/144 (20130101); A61B 2018/00601 (20130101); A61B
2018/00553 (20130101); A61B 2018/00172 (20130101); A61B
2018/00178 (20130101) |
Current International
Class: |
A61B
18/14 (20060101); A61B 18/00 (20060101) |
Field of
Search: |
;606/39,41,45,46,48 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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1 864 621 |
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Dec 2007 |
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EP |
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2008 253541 |
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Oct 2008 |
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JP |
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WO 2007/149263 |
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Dec 2007 |
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WO |
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WO 2008/033929 |
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Mar 2008 |
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WO |
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Other References
International Search Report dated May 28, 2014 for International
Application No. PCT/US2014/017561. cited by applicant.
|
Primary Examiner: Giuliani; Thomas
Attorney, Agent or Firm: Brinks Gilson & Lione
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit under 35 U.S.C. .sctn. 119 of
U.S. Patent Application No. Ser. No. 61/779,986 filed Mar. 13,
2013; which is incorporated by reference in its entirety.
Claims
The invention claimed is:
1. An electrosurgical device comprising: a rotation mechanism
comprising: a first connector; and a second connector, the first
connector rotatable relative to the second connector; a handle
operably connected to the first connector; a catheter operably
connected to the second connector, the handle rotatable relative to
the catheter; a first wire having a distal portion anchored to a
distal portion of the catheter, the distal portion of the wire
being orientable by rotation of the handle relative to the
catheter; at least one of the rotation mechanism or a proximal
portion of the wire forming a conductive connection that operably
connects a power source to the distal portion of the first wire to
energize the distal portion of the first wire in the
electrosurgical device; and a return electrode comprising a first
portion operably connected to the first connector and a second
portion operably connected to the second connector, the first
portion free from direct connection to the second portion so that
the first wire is orientable without interference from the return
electrode.
2. The electrosurgical device according to claim 1, wherein one of
the first connector or the second connector comprises one or more
resilient arms.
3. The electrosurgical device according to claim 2, wherein the one
of the first connector or the second connector comprises a
leaf-like projection forming the conductive connection.
4. The electrosurgical device according to claim 1, wherein at
least one of the first connector or the second connector comprises
a tubular member.
5. The electrosurgical device according to claim 1, wherein the
first connector comprises a conducting region and the second
connector comprises a conducting region to form a rotatable
conduction section of the electrosurgical device.
6. The electrosurgical device according to claim 1, wherein one of
the first connector and the second connector fits at least
partially over the other of the first connector and the second
connector to form a rotatable conductive connection.
7. The electrosurgical device according to claim 1, wherein the
first connector is operably connected to the power source.
8. The electrosurgical device according to claim 1, wherein the
rotation mechanism is provided within a housing.
9. The electrosurgical device according to claim 8, wherein the
housing longitudinally secures the first connector relative to the
second connector.
10. The electrosurgical device according to claim 8, wherein the
housing comprises an injection port positioned distal to the
rotation mechanism.
11. The electrosurgical device according to claim 1, wherein the
rotation mechanism further comprises one or more rings surrounding
the first connector and/or the second connector to provide a
friction between the first and second connectors to control torques
required to rotate the handle relative to the catheter.
12. The electrosurgical device according to claim 1, wherein one or
more resilient arms of the first or second connector or a leaf-like
projection of the first or second connector provides a friction
between the first and second connectors to control torques required
to rotate the handle relative to the catheter.
13. An electrosurgical device comprising: a rotation mechanism
comprising: a first connector comprising a conducting region; and a
second connector comprising a conducting region, the first
connector rotatable relative to the second connector and the second
connector forming a rotatable conductive connection to the first
connector; a handle operably connected to the first connector; a
catheter operably connected to the second connector, the handle
rotatable relative to the catheter; a first wire operably connected
to the handle and the catheter, the first wire electrically
isolated from the first connector and the second connector, the
first wire comprising a first electrode; and a second electrode
comprising a first portion operably connected to the first
connector and a second portion operably connected to the second
connector, the first portion free from direct connection to the
second portion so that the first wire is orientable without
contacting the second electrode.
14. The electrosurgical device according to claim 13, wherein the
rotation mechanism further comprises one or more rings surrounding
the first connector or the second connector, or one or more
resilient arms or leaf-like projections on the first connector or
the second connector to provide a friction between the first and
second connectors to control torques required to rotate the handle
relative to the catheter.
15. The electrosurgical device according to claim 14, wherein the
other of the first connector and the second connector comprises a
tubular member that fits at least partially over the one or more
resilient arms or the leaf-like projections.
Description
BACKGROUND
The present devices relate to medical devices, and in particular to
electrosurgical devices having a conductive component such as a
bipolar or monopolar device.
In endoscopic, or other minimally invasive surgery, generically
referred to herein as endoscopic surgery, a sphincterotome may be
used in conjunction with an endoscope to provide surgical cutting
inside a patient. Specifically, a sphincterotome is used during
certain procedures to make an incision in a sphincter. For example,
a common treatment of cholecystitis includes the removal of
gallstones from the common bile duct. This is frequently done
endoscopically with the use of a duodenoscope. The common bile duct
proceeds from the junction of the common hepatic duct with the
cystic duct, which is open to the gall bladder, and merges with the
pancreatic duct, forming the ampulla of Vater, which itself opens
into the duodenum at the papilla of Vater. The sphincter of Oddi is
a muscular ring that controls passage of fluid from the ampulla of
Vater into the duodenum. For removal of gallstones in an endoscopic
procedure, access to the common bile duct for removal of gallstones
is eased using a sphincterotome to incise or sever the sphincter of
Oddi. The sphincterotome is introduced through the duodenoscope and
guided through the duodenum to the common bile duct. Once the
sphincterotome is guided into the sphincter, its cutting element,
commonly a cutting wire, is used to incise the sphincter, and
thereby improve access to the bile duct and impacted
gallstones.
Another example of a common procedure utilizing a sphincterotome is
endoscopic retrograde cholangiopancreatography (ERCP), a diagnostic
visualization technique used for a variety of clinical
applications. In this procedure, a contrast fluid such as a
radio-opaque dye is introduced through a tube into the ampulla of
Vater. A sphincterotome is often employed to provide access through
the sphincter of Oddi. ERCP is often used in diagnosis of
cholecystitis, as well as in the diagnosis and treatment of other
conditions of the pancreatic and common bile ducts and related
structures.
One problem associated with the use of a cutting wire on a
sphincterotome or other device is that the cutting wire is
difficult to orient for cannulation and cutting of the sphincter.
The correct orientation of the cutting wire relative to the
sphincter is important for proper cutting of the sphincter to
provide access through the sphincter. In addition, the
sphinctertome or other device may be used to navigate into smaller
branches of the ductal system where rotation of the cutting wire
may be necessary to provide access to the desired ducts. Rotation
of the cutting wire may be difficult due twisting of the wire
relative to other features of the device. For example, in a bipolar
device, the cutting wire when rotated may cross over the return
wire.
What is needed in the art is a sphincterotome that is rotatable to
properly orient the cutting wire anchored to the distal portion of
the sphincterotome relative to the tissue. The cutting wire should
be rotatable without interference from other portions of the
device.
BRIEF SUMMARY
Accordingly, it is an object of the present invention to provide a
device and a method having features that resolve or improve on one
or more of the above-described drawbacks.
In one aspect, an electrosurgical device including a rotation
mechanism is provided. The electrosurgical device includes a
rotation mechanism including a first connector; and a second
connector where the first connector is rotatable relative to the
second connector. The electrosurgical device also includes a handle
operably connected to the first connector; and a catheter operably
connected to the second connector where the handle is rotatable
relative to the catheter. The electrosurgical device further
includes a first wire having a distal portion anchored to a distal
portion of the catheter so that the distal portion of the wire is
orientable by rotation of the handle relative to the catheter. At
least one of the rotation mechanism or a proximal portion of the
wire forms a conductive connection that operably connects a power
source to the distal portion of the first wire to energize the
distal portion of the first wire in the electrosurgical device.
In another aspect, an electrosurgical device including a rotation
mechanism is provided. The rotation mechanism includes a first
connector including a conducting region and a second connector
including a conducting region. The first connector is rotatable
relative to the second connector and the second connector forming a
rotatable conductive connection to the first connector to form a
second electrode of the electrosurgical device. The electrosurgical
device also includes a handle operably connected to the first
connector, a catheter operably connected to the second connector
where the handle is rotatable relative to the catheter and a first
wire operably connected to the handle and the catheter. The wire is
electrically isolated from the first connector and the second
connector and the wire is a first electrode.
In another aspect, a method of orienting a distal portion of a wire
of an electrosurgical device is provided. The method includes
operably connecting a proximal portion of the wire to a handle of
the electrosurgical device, anchoring the distal portion of the
wire to a distal portion of a catheter of the electrosurgical
device, connecting a first connector having a conducting region to
the handle and connecting a second connector having a conducting
region to the catheter so that the first connector rotates relative
to the second connector to form a rotatable conducting section of
the electrosurgical device. A proximal portion of the wire forming
a conductive connection that operably connects a power source to
the distal portion of the wire to energize the distal portion of
the wire, the wire comprising a first electrode and the rotatable
conducting second comprising a second electrode. The method further
includes rotating the handle to orient the distal portion of the
wire while hold a proximal portion of the catheter in position.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a sectional view of a rotation mechanism for an
electrosurgical device in accordance with an embodiment of the
present invention;
FIG. 2 is side elevational view of an electrosurgical device
including a rotation mechanism in accordance with an embodiment of
the present invention;
FIG. 3 is a sectional view of a rotation mechanism for an
electrosurgical device in accordance with an embodiment of the
present invention;
FIG. 4 is a sectional view of a rotation mechanism for a bipolar
electrosurgical device in accordance with an embodiment of the
present invention;
FIG. 5 is a sectional view of a rotation mechanism within a housing
in accordance with an embodiment of the present invention;
FIG. 6 is an exploded view of a rotation mechanism in accordance
with an embodiment of the present invention;
FIG. 7 is a perspective view of the first connector of the rotation
mechanism shown in FIG. 6;
FIG. 8 is a perspective view of the first connector and a hub of
the rotation mechanism shown in FIG. 6;
FIG. 9 is a sectional view of a rotation mechanism within a housing
in accordance with an embodiment of the present invention;
FIGS. 10A-10C are partial perspective view of a first connector in
accordance with an embodiment of the present invention; and
FIGS. 11A and 11B illustrate operation of an electrosurgical device
having a rotation mechanism in accordance with the present
invention.
DETAILED DESCRIPTION
The invention is described with reference to the drawings in which
like elements are referred to by like numerals. The relationship
and functioning of the various elements of this invention are
better understood by the following detailed description. However,
the embodiments of this invention are not limited to the
embodiments illustrated in the drawings. It should be understood
that the drawings are not to scale, and in certain instances
details have been omitted which are not necessary for an
understanding of the present invention, such as conventional
fabrication and assembly.
As used in the specification, the terms proximal and distal should
be understood as being in the terms of a physician delivering the
device to a patient. Hence the term "distal" means the portion of
the device that is farthest from the physician and the term
"proximal" means the portion of the device that is nearest to the
physician.
FIG. 1 illustrates an embodiment of a rotation mechanism 10 for use
with an electrosurgical device in accordance with the present
invention. The rotation mechanism can be controlled by providing a
frictional force to overcome in order for the user to be able to
rotate the rotation mechanism. The amount of friction can be
optimized to allow the user to rotate the rotation mechanism yet
sufficient to prevent inadvertent rotation. The control of the
rotation mechanism is described in more detail below. The rotation
mechanism 10 includes a first connector 14 and a second connector
16 that are rotatable relative to each other. As shown in FIG. 1,
the first connector 14 and the second connector 16 may be provided
as tubular cannulae that are sized and shaped so that one of the
first or second connectors 14, 16 fits inside the other of the
first or second connectors 14, 16. As shown in FIG. 1, the first
connector 14 has a slightly smaller diameter d.sub.1 so the first
connector 14 fits into the second connector 16 having a diameter
d.sub.2. The first and second connectors 14, 16 are sized and
shaped so that the first and second connectors 14, 16 can smoothly
rotate relative to each other and in some embodiments may also
maintain contact at all times. The length of the first and second
connectors 14, 16 and the amount of overlap of the first and second
connectors 14, 16 may be varied to optimize the surface contact
between the members 14, 16. In some embodiments, the overlap
between the first and second connector may be about 1 mm to about 5
cm. As shown in FIG. 1, the first connector 14 may be operably
connected to a hub 22 of a handle 24 of an electrosurgical device
26. FIG. 2 illustrates an exemplary electrosurgical device 26
having the handle 24 at a proximal portion 25 of the
electrosurgical device 26. As shown in FIG. 1, the second connector
16 may be operably connected to a catheter 28 of the
electrosurgical device 26. In some embodiments, the first connector
14 may have the larger diameter d.sub.2 and the second connector 16
may have the smaller diameter d.sub.1 so that the second connector
16 fits within the first connector 14. (See FIG. 5.) The first
connector 14 and the handle 24 are rotatable relative to the second
connector 16 and the catheter 28.
In some embodiments, the first and second connectors 14, 16
maintain contact at all times so that an energy, such as but not
limited to RF energy, may be conducted between a conducting region
33 of the first connector 14 and conducting region 37 of the second
connector 16. In some embodiments, the entire first and second
connectors 14, 16 may be formed from an electrically conductive
material to form the conducting regions 33, 37. In some
embodiments, portions of the first and second connectors 14, 16 may
be coated with an insulating material so that conducting regions
33, 37 are positioned to contact each other. In some embodiments,
the first connector 14 may have an outer surface region 32 that is
conductive at a distal end portion 34 of the first connector 14.
The second connector 18 may have an inner surface region 36 that is
conductive at a proximal end portion 38 of the second member 18
when the first connector 14 fits within the second connector 16 so
that the inner and outer conductive surfaces 32, 34 overlap and
contact each other and form a conductive portion 21. In some
embodiments, a nominal resistance of up to about 10 Ohms may be
provided. In some embodiments, the first and second connectors 14,
16 or one of the first and second connectors 14, 16 may be made of
a non-conductive material. Where one or more of the connectors 14,
16 is made of non-conductive material or in addition to a connector
that is made of conductive material, an additional material may be
provided that is conductive or as an alternative to the first and
second connectors 14, 16. By way of non-limiting example, the
conductive regions may be formed of metal strips or sheets, wires,
coils, springs, conducting polymers, conducting inks, combinations
thereof and the like. In some embodiments, the conductive materials
may include stainless steel, steel, tungsten, copper, brass silver,
gold, aluminum, zinc, nickel, bronze, iron, platinum and the like.
An exemplary alternative conductor is shown below in FIG. 6 as a
banana-type connector.
In some embodiments, the rotation mechanism 10 may be used with a
monopolar electrosurgical device so that the first and second
connectors 14, 16 form the conductive connection for a cutting wire
42. As shown in FIG. 2, the cutting wire includes an exposed
portion 42e at a distal end portion 44 of the electrosurgical
device 26 shown in FIG. 2. The cutting wire 42 is anchored at the
distal end portion 44 and the exposed portion 42e is used to cut
the tissue. The cutting wire 42 extends from the distal end portion
44 and is operatively connected to the handle 24 of the
electrosurgical device 26 which is connected to a power supply or
electrosurgical unit 31 through a connector hub 30 on the handle
24. The rotation mechanism 10 shown in FIG. 1 allows the first and
second connectors 14, 16 to rotate relative to each other so that
the handle 24 rotates the cutting wire 42 relative to the catheter
28 so that the exposed portion 42e of the cutting wire 42 at the
distal end portion 44 of the electrosurgical device 26 can be
rotatably positioned so that the exposed portion 42e of the cutting
wire 42 is orientable for cannulation and cutting at a tissue site.
Since the cutting wire 42 is anchored at the distal portion 44 of
the catheter 28, the distal portion 44 of the catheter 28 is moved
with the cutting wire 42 while the remainder of the catheter 28 and
the second connector 16 are not moved by the rotation of the handle
24.
In some embodiments where the electrosurgical device 26 is a
monopolar device, a single wire 42c may extend from the proximal
portion 25 of the handle 24 through the hub 22 to the distal end
portion 44 of the electrosurgical device 26 so that the exposed end
42e of the single wire 42c is exposed for cutting the tissue at the
appropriate site. The cutting wire 42c may extend through a lumen
52 of the first connector 14 and through a lumen 54 of the second
connector 16 as shown in FIG. 3. The cutting wire 42c extends
through the catheter 28 to the distal end portion 44 of the
electrosurgical device 26. Since the cutting wire 42c is positioned
within the lumens 52, 54 of the first and second connectors 14, 16,
the connectors 14, 16 may be rotated relative to each other by
rotating the handle 24 relative to the catheter 28 to position the
exposed cutting portion 42e in the proper orientation without
crossing the cutting wire 42c with any part of the electrosurgical
device 26. With a monopolar device as shown in FIG. 3, the first
and second connectors 14, 16 do not need to be conductive. The
cutting wire 42c may be insulated where the cutting wire extends
through the electrosurgical device 26 until the wire 42 is exposed
at the distal end portion 44. The exposed cutting portion 42e is
free from insulation.
The rotation mechanism 10 may also be used with a bipolar device
having an active and a return wire. An exemplary bipolar
configuration is shown in FIG. 4. FIG. 4 also illustrates the first
connector 14 having the larger diameter d.sub.2 than the second
connector 16 having the smaller diameter d.sub.1 so that the second
connector 16 fits within the first connector 14. The first and
second connectors 14, 16 as shown in FIG. 4 are configured to
maintain contact at all times so that an energy, such as but not
limited to RF energy, may be conducted between the first and second
connectors 14, 16. In some embodiments, the entire first and second
connectors 14, 16 may be formed from an electrically conductive
material. In some embodiments, portions of the first and second
conductive members 14, 16 may be coated with an insulating material
so that conductive portions are positioned to contact each other.
In some embodiments, the first connector 14 may have an inner
surface 35 that is conductive at the distal end portion 34 of the
first connector 14. The second connector 16 may have an outer
surface 39 that is conductive at the proximal end portion 38 of the
second member 18. The first connector 14 fits over the second
connector 16 so that the inner and outer conductive surfaces 39, 35
overlap and contact each other to provide the conductive portion
21. The bipolar configuration for the rotation mechanism 10 may
also have the first connector 14 having the smaller diameter
d.sub.1 and the second connector 16 having the larger diameter
d.sub.2 so that the first connector 14 fits within the second
connector 16 as described above with reference to FIG. 1. By way of
non-limiting example, the conductive portion may be formed of metal
strips or sheets, wires, coils, springs, conducting polymers,
conducting inks, combinations thereof and the like.
As shown in FIG. 4, the bipolar device includes the cutting wire
42c that connects to the handle 24 and extends to the distal end
portion 44 of the catheter 28 so that the exposed cutting portion
42e of the cutting wire 42c forms the active electrode that is
orientable to cut the tissue. The cutting wire 42c extends through
the lumen 52 of the first connector 14 and through the lumen 54 of
the second connector 16. The cutting wire 42c extends through the
catheter 28 to the distal end portion 44 where the cutting wire 42c
is anchored and the cutting portion 42e is exposed. In some
embodiments, the cutting wire 42c may be insulated except for the
exposed portion 42e so that the cutting wire 42c does not contact
the first and second connectors.
A return wire 44 for the bipolar device is shown in FIG. 4 where
the return wire includes a proximal wire 44a that is connected to
the first connector 14 and a distal wire 44b that is connected to
the second connector 16. The proximal and distal return wires 44a,
44b are electrically connected via the conductive portion 21 formed
by the connection of the first and second connectors 14, 16. The
distal wire 44b may extend to the distal end portion 44 to act as
the return wire for the cutting wire 42c. The first connector 14
connected to the handle 24 and the second connector 16 connected to
the catheter 28 are freely rotatable relative to each other. In
this configuration, the cutting wire 42c and the return wires 44a,
44b do not cross each other so the cutting wire 42c can be rotated
in any direction and to any degree to orient the exposed portion
42e for cutting the tissue and cannnulating the papilla. In some
embodiments, the first and/or second connectors 14, 16 may form the
return electrode 44 without including one or both of the proximal
return wire 44a and the distal return wire 44b.
FIG. 5 illustrates the rotation mechanism 10 within a housing 25.
The housing 25 may be configured to hold the first connector 14 and
the second connector 16 together so that a longitudinal position of
the first and second connectors 14, 16 is substantially fixed and
allows the first and second connectors 14, 16 to rotate relative to
each other. In some embodiments, a plurality of rings 30, such as
o-rings, may be used to make a friction fit for the first and
second connectors 14, 16 within the housing 25. The rings 30
prevent inadvertent rotation of the first and second connectors 14,
16 yet allow the user to overcome the frictional forces provided by
the rings 30 when rotation is desired. As shown in FIG. 5, at least
one ring 30 is provided around each of the first and second
connectors 14, 16. Additional rings 30 may also be provided to
increase the amount of frictional force needed to be overcome to
rotate the first and second connectors 14, 16 relative to each
other. The hub 22 may be provided as a ball and socket connection
that connects the first connector 14 to the handle 24. In some
embodiments, the housing 25 may be injection molded although other
methods for forming the housing are also possible.
An alternative embodiment of a bipolar configuration of a rotation
mechanism 100 is shown in FIG. 6. First and second connectors 114,
116 as shown in FIG. 6 are configured to maintain contact so that
an energy, such as but not limited to RF energy, may be conducted
between the first and second connectors 114, 116. The first and
second connectors 114, 116 are similar to the first and second
connectors described above and may include features similar to the
first and second connectors 114, 116 described above however, the
configuration of the first connector 114 is different. The first
connector 114 shown in FIG. 6 may be provided as a banana-type
connector. The first connector 114 includes one or more resilient
arms 160 that bow outward from a center longitudinal axis 162 of
the first connector 114. The amount of curve of the arms 160 can
control the amount of force needed to rotate the first connector
114 relative to the second connector 116 and can also improve the
electrical connection between the first and second connectors 114,
116. Other forms of connector in addition to the banana-type
connector that include one or more resilient arms may also be used
where at least one arm forms a connection with the second
connector. The first connector 114 is shown connected to a hub 122
that connects to the handle 124 of the electrosurgical device 126.
A tubular member 115 may extend through an inner portion 164 of the
first connector 114. In some embodiments, the tubular member 115
may be made from an insulating material and include a lumen 167
extending therethrough to accommodate a cutting/active wire 142c
extending through the lumen 167 as shown in FIG. 7. FIG. 8
illustrates a top perspective view of the hub 122 connected to the
first connector 114 and showing a proximal return wire 144a
extending proximally through an offset opening 145. As shown in
FIG. 8, the proximal return wire 144a is offset from a center
opening 146 that connects to the lumen 160 of the tubular member
115 and through which the cutting wire 142c extends. In some
embodiments, the proximal return wire 144a may be centrally
positioned and the cutting wire 142c may be offset from the center
opening 146. The hub 122 keeps the cutting wire 142c away from the
proximal return wire 144a. In some embodiments, the first connector
114 may not include the proximal return wire 144a to complete the
return electrode 144 and may be directly connected to the power
source. The second connector 116 may be connected to a distal
return wire 144b in the catheter 28.
As shown in FIG. 6, the second connector 116 is sized and shaped to
fit over the first connector 114 and to contact the resilient arms
160. At least a portion of the first connector 114 is formed of a
conductive material so that when the second connector 116 is
advanced over the first connector 114, the resilient arms 160
contact an inner surface 136 of the second connector 116 to form a
conductive portion 121 (see FIG. 9). In some embodiments, the
second connector 116 may be provided as a banana-type connector or
other type connector having one or more resilient arms and the
first connector 114 may be provided as a tubular member that fits
over the second connector 116.
As shown in FIG. 6, the bipolar device includes the cutting wire
142c that connects to the handle 124 of the electrosurgical device
126 shown in FIG. 6 and extends to the distal end portion 144 of
the catheter 128 so that the exposed cutting portion 142e of the
cutting wire 142c forms the active electrode that is orientable to
cut the tissue. The cutting wire 142c extends through the lumen 160
of the tubular member 115 within the first connector 114 and
through a lumen 154 of the second connector 116. The cutting wire
142c extends through the catheter 128 to the distal end portion 144
where the cutting wire 142c is anchored. The handle 124 may be
rotated to rotate the cutting wire 142c to orient the exposed
portion 142e for cutting and the distal portion 144 of the device
for cannulation.
A return wire 144 for the bipolar device is shown in FIG. 6 where
the return wire includes a proximal return wire 144a that is
connected to the first connector 114 and a distal return wire 144b
that is connected to the second connector 116. The proximal and
distal return wires 144a, 144b are electrically connected via the
conductive portion 121 formed by the connection of the first and
second connectors 114, 116. The distal wire 144b may extend to the
distal end portion 144 of the catheter 128 to act as the return
wire for the cutting wire 142c. The first connector 114 connected
to the handle 124 and the second connector 116 connected to the
catheter 128 are freely rotatable relative to each other. The arms
160 of the first connector 114 help to maintain the electrical
connection between the first connector 114 and the second connector
116 and still allow the first and second connectors 114, 116 to
rotate relative to each other. In this configuration, the cutting
wire 142c and the return wires 144a, 144b do not cross each other
so the cutting wire 142c can be rotated in any direction and to any
degree to orient the exposed portion 142e for cutting the tissue.
The wires 144a, 144b together with the conductive portion 121 of
the first and second connectors 114, 116 form the return electrode
144.
FIG. 9 illustrates the rotation mechanism 100 with the first and
second connectors 114, 116 connected and positioned within a
housing 125. The second connector 116 is positioned over the first
connector 114 and the first and second connectors 114, 116 are held
substantially longitudinally fixed relative to each other within
the housing 125. The first connector 114 is rotatable within the
housing and the second connector 116 by rotation of the handle 124.
In some embodiments, the housing 125 may include a port 166 that is
positioned distal to the rotation mechanism 100. The port 166
includes a lumen 168 that connects to a lumen 170 of the catheter
128.
FIGS. 10A-10C illustrate an alternative embodiment of a first
connecting member 214. The first connecting member 214 may be used
in combination with the second connectors 16, 116 described above
and may include any of the features described above. As shown in
FIGS. 10A and 10B, the first connector may include one or more
spring-like leaves 217 to form the electrical connection with the
second connector 16, 116. FIG. 10C shows an embodiment having two
spring-like leaves 217 on an end 221 of the first connector 214.
The spring-like leaves 217 may be formed by partially separating a
portion from the main body and reshaping the portion as a leaf
shape having an outer diameter 223 that is larger than the inner
diameter of the second connector 16, 116 so that the leaf 217 forms
the electrical connection between the first and second connectors
214, 16, 116. The leaf 217 is resilient and can be moved inward to
allow the second connector 16, 116 to be positioned over the leaf
217. The leaf 217 is resilient to provide and maintain the
conductive connection to the second member 16, 116 and to also
provide some frictional resistance to avoid inadvertent rotation.
As shown in FIG. 10C, the spring-like leaf 217 may also be formed
at any position on the first connector 214. Any number of leaves
217 may be included. The leaves 217 may have any shape and
configuration that provides a connection between the first
connector 214 and the second connector 16, 116. The leaves may be
formed by laser cutting, stamping and the like. In some
embodiments, the leaves 217 may be made as separately and joined to
the first connector 214 by welding, soldering, riveting or other
joining methods know to one skilled in the art. In some
embodiments, the second connector may include one or more leaves
that project inward toward the first connector and in some
embodiments, both the first and second connectors may include
leaves.
An exemplary procedure utilizing the rotation mechanism 10, 100 as
part of a sphincterotome, for example in accessing the biliary
system via the Sphincter of Oddi is shown in FIGS. 11A and 11B and
is described as follows. An endoscope 359 is advanced into the
patient and positioned near the Sphincter of Oddi 361 in the
Papilla of Vater 363. The endoscope 359 is positioned to allow
viewing of sphincter 361 as is known. The catheter 128 is extended
into engagement with sphincter 361 by inserting the distal end
portion 144 of the catheter into the Ampulla of Vater, which
communicates with the common bile duct 367 and the pancreatic duct
369. The catheter 128 may be rotated using the wire 142 for
cannulation of the Papilla 363. The catheter 128 may be extended
into the Ampulla of Vater until the cutting wire 142c and the
portion to be used for cutting 142e is longitudinally aligned with
the stricture to be cannulated. The handle 124 is rotated as
indicated by the arrow shown in FIG. 9 to move the cutting wire
142c and the exposed portion 142e into the proper orientation for
cutting the tissue. The cutting wire 142c rotates with the handle
124 and the first connector 114 so that the distal portion 144 of
the catheter 128 is rotated where the cutting wire 142c is anchored
to the distal portion 144. The remainder of the catheter 128 does
not rotate. The cutting wire 142c freely rotates and does not cross
any other portions of the device. Once the exposed portion 142e is
correctly oriented, the cutting wire 142c is energized and the
tissue is cut. The return wire 144 maintains the circuit from the
distal return wire 144b connected to the second connector 116 which
is conductively connected to the first connector 114 that has the
proximal return wire 144a connected thereto. If a second cut is
needed, requiring a different orientation for the exposed portion
142e of the cutting wire 142c, the handle 124 may be rotated to
move the cutting wire 142c so that the exposed portion 142e is in
the proper orientation for the second cut. The catheter 128 may
also be used to for selective cannulation of branches in the
biliary tree where rotation of the distal portion 144 of the
catheter 128 is necessary for cannulation of the branches.
The above Figures and disclosure are intended to be illustrative
and not exhaustive. This description will suggest many variations
and alternatives to one of ordinary skill in the art. All such
variations and alternatives are intended to be encompassed within
the scope of the attached claims. Those familiar with the art may
recognize other equivalents to the specific embodiments described
herein which equivalents are also intended to be encompassed by the
attached claims.
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